COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04338009

Jordana B. Cohen

Not reported

2020-04-08

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: age 18 years or older hospitalization with a suspected diagnosis of covid-19, based on: (a) a compatible clinical presentation with a positive laboratory test for sars-cov-2, or (b) considered by the primary team to be a person under investigation due to undergo testing for covid-19 in addition to compatible pulmonary infiltrates on chest x-ray (mutilobar, intersticial or ground glass opacities). use of acei or arb as an outpatient prior to hospital admission.

systolic blood pressure <100 mmhg. systolic blood pressure > 180 mmhg or >160 if unable to substitute aceis/arbs for another antihypertensive class, per the investigator's discretion. diastolic blood pressure > 110 mmhg known history of heart failure with reduced ejection fraction (ef <40%) on their most recent echo and/or clinical heart failure with unknown ef (i.e. no echo in approximately the past year). serum k>5.0 meq/l on admission. known pregnancy or breastfeeding. egfr <30 ml/min/1.73m2 >50% increase in creatinine (to a creatinine >1.5 mg/dl) compared to most recent creatinine in the past six months, if available urine protein-to-creatitine ratio > 3 g/g or proteinuria > 3 g/24-hours within the past year ongoing treatment with aliskiren or sacubitril-valsartan. inability to obtain informed consent from patient. inability to read and write or lack of access to a smart phone, computer or tablet device at the time of evaluation.

2

University of Pennsylvania

18

100

United States

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

152

Hierarchical Composite Endpoint

None

Not reported

[{"arm_notes": "Participants received intervention already before enrollment. Treatment was continued and discontinued.", "treatment_id": 1410, "treatment_name": "Ace inhibitor+angiotensin receptor blocker (arb)", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]